NCT06229873

Smartphone App-guided Inspiratory Muscle Strength Training for Lowering Systolic Blood Pressure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of Colorado, Boulder · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This clinical trial aims to assess the efficacy of inspiratory muscle strength training (IMST) guided by a smartphone app vs. IMST delivered in a clinical research setting for lowering systolic blood pressure in adults 18 years and older with elevated blood pressure. Participants will perform IMST for 5 minutes a day, 6 days a week, for 6 weeks.

Detailed description

Having above-normal blood pressure, i.e., ≥120 mmHg systolic blood pressure (SBP) and/or ≥80 mmHg diastolic blood pressure (DBP), increases risk of developing cardiovascular diseases, cognitive decline/dementia, chronic kidney disease, and other chronic health problems. Approximately 60% of all US adults have above-normal BP, primarily driven by above-normal SBP. Currently, above-normal SBP is the single largest modifiable risk factor for cardiovascular mortality in the United States. Thus, developing novel strategies for lowering SBP is an urgent public health and biomedical research priority. Guidelines emphasize regular aerobic exercise as a first-line intervention for all stages of above-normal systolic blood pressure (SBP). Current guidelines call for ≥150 minutes of aerobic activity per week. However, only \~50% of US adults meet these aerobic exercise guidelines. The greatest reported barrier to achieving aerobic exercise guidelines is lack of time. High-resistance inspiratory muscle strength training (IMST) is a time-efficient (5 minutes per session) lifestyle intervention consisting of 30 inspiratory maneuvers performed against a high resistance. Preliminary data suggest 6-weeks of IMST performed 6 days/week reduces SBP by 9 mmHg in adults with above-normal SBP (i.e., greater than 120 mmHg) at baseline. Importantly, this reduction in SBP is equal to or greater than the reduction in blood pressure typically achieved with time- and effort-intensive healthy lifestyle strategies like conventional aerobic exercise. The investigators hope utilizing a smartphone app to guide IMST will promote the translation of IMST for widespread use and improving public health. The investigators will conduct a randomized, controlled, single-blind, parallel group design clinical trial to assess the efficacy of 6-weeks of IMST (55%-75% maximal inspiratory pressure) delivered in the research clinic by the study investigators vs. IMST delivered entirely via a smartphone app without investigator involvement, for lowering resting and home SBP in adults aged 18 years and older with above-normal SBP (120-160 mmHg) at baseline. The investigators will also assess the effect of IMST on endothelial function, large-elastic artery stiffness, and potential mechanisms of action.

Conditions

• Blood Pressure
• Vascular Function
• Adherence, Treatment

Interventions

Type	Name	Description
DEVICE	App-Based Inspiratory Muscle Strength Training	Participants will perform inspiratory muscle strength training guided by a smartphone application. Participants will perform 30 breaths a day at 75% of maximal inspiratory pressure, 6 days a week, for 6 weeks. All training sessions will be guided by the smartphone application.
DEVICE	Clinic-Based Inspiratory Muscle Strength Training	Participants will perform inspiratory muscle strength training guided by researchers. Participants will perform 30 breaths a day at 75% of maximal inspiratory pressure, 6 days a week, for 6 weeks. One training session each week will be performed in the research clinic.

Timeline

• Start date: 2024-07-11
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-01-29
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study